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Comparative Evaluation of the McGrath Videolaryngoscope and the Direct Laryngoscopy for Tracheal Intubation in the Prehospital Setting (AMAC)

14. juni 2021 opdateret af: Assistance Publique - Hôpitaux de Paris

In the prehospital setting, the risk of difficult intubation and life-threatening complications is increased under particular conditions due to the environment or the frequent instability of patients.

To limit this risk procedures and devices to ease and secure tracheal intubation must be developped and integrated.

As the prevalence of complications increase with the number of attempts of intubation, one strategy is to facilitate the intubation technic itself.

Direct laryngoscopy with Macintosh blades is the standard device commonly used in first place for tracheal intubation.

Other devices are available and used, mostly for difficult intubation, included videolaryngoscopy. This device has been used and studied for years now. Allowing a better view and glottic visualisation, videolaryngoscopy could increase the first-pass success rate.

Among all videolaryngoscopes, the McGrath videolaryngoscope is the most similar device to the standard Macintosh laryngoscope. It is light, compact, with a screen directly linked to the handle, easy to use and offering excellent view. Its usability and efficacy make it a device of choice for the prehospital setting and worth further clinical trials to define its place in the airway strategy.

Hypothesis: In the prehospital setting, the use of McGrath videolaryngoscope as the primary device for tracheal intubation could facilitate tracheal intubation and decrease the number of attempts of intubation and complications.

The objective of our study is to determine if the use of McGrath videolaryngoscope increase the rate of successful first-pass intubation in the prehospital setting compared to direct view Macintosh laryngoscopy.

The primary outcome is the rate of successful intubation at the first attempt. One attempt is defined as an advancement of the tube towards the glottis during a laryngoscopy ; every new try even during the same laryngoscopy is considered as a new attempt.

Successful intubation is confirmed by the visualisation of 6 waves of EtCO2.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

150

Fase

  • Fase 3

Kontakter og lokationer

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Studiekontakt

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Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age more than 18
  • Indication of orotracheal intubation
  • Operators trained to the use of the McGrath

Exclusion Criteria:

  • Pregnancy
  • No insurance
  • Major patient under guardianship or curatorship

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Videolaryngoscopy group
Enhed: Videolaryngoscopy group
Tracheal intubation will be performed using Videolaryngoscope in first intention and will be performed using standard pre-hospital intubation procedures : preoxygenation before intubation, maintenance of oxygenation throughout procedure, standard sedation technique (using rapid sequence intubation (RSI)), correct position confirmation using a capnogram and conditioning (hemodynamic monitoring, respirator settings, securing). If the first attempt at intubation is unsuccessful, further management will be left to the discretion of the clinician according to the procedures and algorithm of usual standard care
Andet: Direct laryngoscopy group
Enhed: Direct laryngoscopy group
Tracheal intubation will be performed using Direct laryngoscopy with Macintosh blades in first intention. and will be performed using standard pre-hospital intubation procedures : preoxygenation before intubation, maintenance of oxygenation throughout procedure, standard sedation technique (using rapid sequence intubation (RSI)), correct position confirmation using a capnogram and conditioning (hemodynamic monitoring, respirator settings, securing). If the first attempt at intubation is unsuccessful, further management will be left to the discretion of the clinician according to the procedures and algorithm of usual standard care

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of successful intubation at the first attempt
Tidsramme: up to 10 minutes post inclusion
One attempt is defined as an advancement of the tube towards the glottis during a laryngoscopy ; every new try even during the same laryngoscopy is considered as a new attempt.Successful intubation is confirmed by the visualisation of 6 waves of EtCO2.
up to 10 minutes post inclusion

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of attempts needed for successful intubation
Tidsramme: up to 10 minutes post inclusion
up to 10 minutes post inclusion
Time to intubate
Tidsramme: up to 10 minutes post inclusion
Time to intubate will be defined by the time between the insertion of the device in the mouth and the visualisation of the first waves of EtCO2
up to 10 minutes post inclusion
Reason of failure of the first-pass success
Tidsramme: up to 10 minutes post inclusion

Reasons of failure will be defined as following :

  • Bad glottic visualization
  • Difficult progression of the tube towards the glottis despite a good visualisation
  • Presence of secretions
  • Presence of foreign body
  • Presence of fogging on the McGrath
  • Device failure
  • Other
up to 10 minutes post inclusion
Proportion of decision of switch in case of failure
Tidsramme: up to 10 minutes post inclusion
up to 10 minutes post inclusion
Proportion of difficult intubations
Tidsramme: up to 10 minutes post inclusion
Difficult intubation will be evaluated by the intubation difficulty score (score IDS or difficulty of intubation under laryngoscopy score ). It goes from 0 to infinity. zero indicating an easy intubation and infinity being an impossible intubation
up to 10 minutes post inclusion
Glottic view
Tidsramme: up to 10 minutes post inclusion
Glottic view will be evaluated with Cormack and Lehane grade and POGO score. POGO score goes from 0 (Visualization of the language base) to 100% (total visualization of the glottis). Cormack and Lehane grade goes from I to IV. A higher Cormack and Lehane grade is worth : I indicate total visualization of the glottis and IV indicate Visualization of the language base
up to 10 minutes post inclusion
Proportion of cases who need for tools to optimize
Tidsramme: up to 10 minutes post inclusion
up to 10 minutes post inclusion
Proportion of cases needed crossovers to other rescue techniques
Tidsramme: up to 10 minutes post inclusion
up to 10 minutes post inclusion
Number of complications per and post-intubation
Tidsramme: up to 10 minutes post inclusion
up to 10 minutes post inclusion
Type of complications per and post-intubation
Tidsramme: up to 10 minutes post inclusion
up to 10 minutes post inclusion
Number of deaths
Tidsramme: up to 10 minutes post inclusion
up to 10 minutes post inclusion

Samarbejdspartnere og efterforskere

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Sponsor

Assistance Publique - Hôpitaux de Paris

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

15. juni 2021

Primær færdiggørelse (Forventet)

15. december 2021

Studieafslutning (Forventet)

15. december 2021

Datoer for studieregistrering

Først indsendt

7. juni 2021

Først indsendt, der opfyldte QC-kriterier

14. juni 2021

Først opslået (Faktiske)

18. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juni 2021

Sidst verificeret

1. maj 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • K170405J

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